1. Field of the Invention
The present invention relates to an apparatus and related method for making surgical sutures and, in particular, sutures for connecting two open sections of a duct or tubular element of the human or animal body.
2. Description of the Related Art
As is well-known, a stapler for surgical operations is used for carrying out the mechanical connection, followed by the natural biological connection, of two open sections of ducts of the human or animal body. The two sections are previously prepared with the aid of equipment suitable for forming onto the ends of the sections a binding of the type known as a "purse bag". The stapler is introduced into one of the two sections through an opening that is accessible (e.g. in the intestine, through the rectum), until its end reaches the zone of operation where the separated sections are pressed by a cartridge fixed to the head of the stapler and are joined mechanically through staples supplied from the cartridge. The excess organic tissue part in the inside of the duct is removed by a punching operation performed by the same stapler after the stapling. Thereafter, by extracting the stapler out of the opening (e.g. the rectum), the excess tissue cut by the hollow punch is recovered. After a certain time, organic uniting of the two sections in the connection zone occurs, and the tissue mechanically joined through the staples is eliminated naturally by excretion.
Systems and equipment for carrying out this important surgical operation are widely described in the literature. For example, U.S. Pat. No. 4,485,817 describes a stapler including: a head for applying staples to the tissue, including a member for the application of the staples from a cartridge, and an anvil; means for controlling the elements of the head; and drive means between the head and the control means, including a flexible shaft that can be bent during insertion and can be adapted to the configuration of the opening of the human body and can hold the assumed configuration during the operation.
The equipment described in this patent reference has various advantages--in particular, that of providing a surgical stapler with a flexible shaft--but it also has many drawbacks, including the irremovability of the head, the necessity of adjusting it "in situ", its operation by compression and, above all, the necessity of having a large diameter of the articulated pipe to be introduced into the duct to be sutured. In all cases, this diameter cannot be reduced to make insertion easier. Further, the control is rather complex and its flexibility and memory are limited.
For the purpose of explanation, FIG. 18 shows the operative method of the conventional equipment, including the one according to U.S. Pat. No. 4,485,817. As shown in FIG. 18, phase I includes inserting the stapler with a closed head (with diameter e.g. of 32 mm); phase II comprises opening the head in the inside of the intestinal duct (turning the pushbutton of the control device); phase III comprises forming the tobacco purse; phase IV is the closing of the cartridge (turning the pushbutton in opposite direction); and phase V comprises the operation of stapling and hollow punching.
The whole operation is painful for the patient and also requires complicated efforts by the surgeon who must perform all these phases and motions manually.